Clinical Research Associate I

Key Accountabilities:

Maintenance (from initiation through close out):

Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.

• Build relationships with investigators and site staff.

• Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

• Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

• Address/evaluate/resolve issues pending from the previous visit, if any.

• Follow-up on and respond to appropriate site related questions.

• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.

• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

• Conduct remote visits/contacts as requested/needed.

• Generate visit/contact report.

• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

• Assess & manage test article/study supply including supply, accountability and destruction/return status.

• Review & follow-up site payment status.

• Follow-up on CRF data entry, query status, and SAEs.

• Conduct on-site study-specific training (if applicable).

• Perform site facilities assessments

• Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Skills:

• Sound problem solving skills.

• Able to take initiative and work independently, and to proactively seek guidance when necessary.

• Advance presentation skills.

• Client focused approach to work.

• Ability to interact professionally within a client organization.

• Flexible attitude with respect to work assignments and new learning.

• Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.

• Willingness to work in a matrix environment and to value the importance of teamwork.

• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

• Strong interpersonal, verbal, and written communication skills.

• Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.

• Effective time management in order to meet study needs, team objectives, and department goals.

• Developing ability to work across cultures.

• Shows commitment to and performs consistently high-quality work.

• Ability to successfully work in a (‘virtual’) team environment.

• Consulting Skills

• Great attention to detail.

• Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.

• Holds a driver’s license where required.

Knowledge and Experience:

• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience